Cardiac RadiothErapy for VEntricular Tachycardia

NCT05973578 | Recruiting

• 1 other identifier: s66934
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To explore in our center the feasibility and safety of a SBRT treatment method for VT. Study population: Patients with ventricular tachycardia that are refractory to dose-escalated antiarrhythmic drugs and where catheter ablation has either already been performed or is deemed to be unsuccessful or associated with high risks. Intervention: Patients will be treated with a stereotactic body radiotherapy technique as a single fraction treatment up to a dose of 25 Gy delivered to the VT substrate defined by electrophysiological mapping. Main study endpoints: The primary aim is to explore the feasibility and safety of a SBRT treatment method for refractory VT. Secondary endpoints include an assessment of the efficacy of the treatment, quality of life, late toxicity and overall survival. Patients will have to fill in a quality-of-life questionnaire before and after the radiotherapy treatment. The risk associated with this trial is an increase in toxicity.

Conditions

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

• Feasibility of SBRT

  Successful irradiation process (collaboration with cardiologist and radiologist), measured by the end-to-end delivery of SBRT to at least 1 patient

  From date of inclusion up to 1 year

• Safety of SBRT

  Measurement of acute and late toxicity assessed using the CTCAE v5.0

  From radiotherapy up to 1 year

Secondary Outcomes (2)

• Efficacy of SBRT

  From inclusion up to 1 year

• Health related quality-of-life

  From inclusion up to 1 year

Study Arms (1)

Stereotactic body radiotherapy

OTHER

Patients will be treated with a stereotactic body radiotherapy technique as a single fraction treatment up to a dose of 25 Gy delivered to the VT substrate

Radiation: Stereotactic radiotherapy

Interventions

Stereotactic radiotherapy RADIATION

Single-session high dose stereotactic radiotherapy

Stereotactic body radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 years
• Presence of a structural heart disease and an implantable cardioverter defibrillator (ICD)
• Documented sustained monomorphic VT that requires ICD intervention (e.g., shock or anti-tachycardia stimulation)
• The VT is inducible by ICD via non-invasive programmed stimulation (NIPS) or during electrophysiology measurement
• Patient must have failed or become intolerant to at least one antiarrhythmic medication
• Patient must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure, or have VT thought to arise from a protected location
• Ability to give a written informed consent and willingness to return for follow-up

You may not qualify if:

• Pregnancy or breastfeeding
• Lack of evidence of a myocardial scar triggering the VT
• Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm
• Advanced symptomatic heart failure defined as NYHA Class IV heart failure
• Previous radiotherapy with cardiac involvement
• Life expectancy \< 6 months, in the absence of VT, as best based on clinical judgment by the treating and enrolling physicians
• Any condition that is deemed a contraindication in the judgment of the investigators

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Patrick Berkovic, MD, PhD

CONTACT

+32-16-34-51-15; Patrick.berkovic@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: August 3, 2023
• Study Start: May 23, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: August 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)